initial thoughts:
The ALK+ response met what were very high expectations. I suspect that both response rates and duration will continue to improve as the dose escalates. There aren't a lot of egfr data points yet but I'm encouraged that they are dosing at 240mg and are showing activity. The brain mets response was nice to see however it's important to note that LDK378 and CH5424802 also showed brain met activity.
Will AP113 be ALK+ NSCLC best-in-class? In crizotinib resistant pts, AP113 showed a 67% response rate and a 6 month duration while LDK378 had less than a 50% (21/45) response rate and a 7.4 month duration. Once the MTD is determined, I suspect AP113 will demonstrate both greater efficacy and duration of response.
CH5424802 is the one to keep an eye on, especially in treatment naive pts where it achieved an 85% response rate but I'm not sure what the duration of this response has been. Also, in comparison to the AP113, the CH5424802 trial appears to have a somewhat more restrictive enrollment criteria which makes a direct comparison more difficult, however, it is worth noting that in the AP113 trial both of the evaluable ALK+ naive patients achieved a PR. At this point, we simply need more data points at AP113's MTD but based on these very early results, it appears that AP113 will exceed LDK378 in resistant pts and at least meet CH5424802 in the treatment naive population.
Overall, the results, while early, are certainly compelling.
